A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

Launched by NIKANG THERAPEUTICS, INC. · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medicine called NKT5097 in adults who have advanced or spreading solid tumors, including different types of breast, ovarian, and uterine cancers. The main goal is to find out how safe the medicine is, what side effects it might cause, and the best dose to use in future studies. This early-phase study is especially focused on certain breast cancers and tumors with a specific genetic change called CCNE1 amplification.

Adults 18 years and older with advanced tumors that cannot be removed by surgery and who have not responded well to other treatments may be able to join. Participants should be in generally good health aside from their cancer and able to take oral medication. People with certain heart problems, active infections, or other serious health issues may not be eligible. Those who join will be closely monitored to see how they tolerate the medicine and how their cancer responds. The study is currently looking for volunteers of all genders who meet these criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Able to provide written informed consent
• • Advanced unresectable or metastatic solid tumor
• • Refractory to or unable to tolerate existing therapies (Part 1 \& 2 only)
• • Measurable or evaluable disease (Part 1 \& 2 only)
• • Eighteen years of age or older
• • ECOG status of 0 or 1
• • Adequate organ function
• • Patients with female reproductive organs must be surgically sterile, post- menopausal or willing to use effective contraception per protocol
• • Patients who are capable of insemination must be willing to use highly effective contraception and to refrain from sperm donation during treatment and for 28 days after the last dose
• • Able to swallow oral meds
• • Willing to provide tumor tissue
• Exclusion Criteria:
• • Advanced solid tumor that is a candidate for curative treatment
• • History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage I or Stage II cancers currently in complete remission
• • Not recovered from the effects of prior anticancer therapy
• • Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months
• • Known active CNS metastases and/or carcinomatous meningitis
• • Active interstitial lung disease requiring treatment
• • History of uveitis, retinopathy, or other clinically significant retinal disease
• • Major surgery within 30 days of administration of first dose
• • Active uncontrolled infectious disease
• • Significant liver disease (Child Pugh class B or C)